Patheon Biologics Australia Pty Ltd.
Form 483 issued October 17, 2023 · Woolloongabba, Australia
- Inspection
- Oct 9 – Oct 17, 2023
- Investigators
- Michael R. Shanks· Yun Wu
- Observations
- 2
- Pages
- 2
- FEI number
- 3010976475
In short: On October 17, 2023, FDA issued a Form 483 with 2 observations to Patheon Biologics Australia Pty Ltd. in Woolloongabba, Queensland (FEI 3010976475) after an inspection that ran Oct 9 – Oct 17, 2023. The investigators were Michael R. Shanks and Yun Wu. Most observations concern materials and facilities & equipment; the most-cited regulation is 21 CFR 211.84 (testing and approval or rejection of components, drug product containers, and closures).
At a glance
Materials and facilities & equipment account for 2 of 2 observations.
Most cited: 21 CFR 211.84 (1×) · 211.68 (1×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Identity and suitability of incoming critical materials and components used for (b)(4) manufacture are not…
- 02
User access controls are not always adequate to protect electronic data acquisition systems used for testing…
This inspection in context
Michael R. Shanks
27 documents · 2017–2024
Cites 211.113 (control of microbiological contamination) more than any other section. Most of their documents are for sites in California.
The firmPatheon Biologics Australia Pty Ltd. history
The site's inspection history, in date order.
Similar 483sOther sites cited under 211.84
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Patheon Biologics Australia Pty Ltd.?
FDA listed 2 observations on this Form 483, mostly about materials and facilities & equipment. The most-cited regulation is 21 CFR 211.84 (testing and approval or rejection of components, drug product containers, and closures). The opening words of each observation are shown on this page.
Who inspected Patheon Biologics Australia Pty Ltd.?
Michael R. Shanks and Yun Wu are named on this Form 483, for the inspection of Oct 9 – Oct 17, 2023. Each investigator has a profile showing what they cite most.
When was Patheon Biologics Australia Pty Ltd. inspected by FDA?
The inspection ran Oct 9 – Oct 17, 2023, and the Form 483 is dated October 17, 2023.
How do I get the full Form 483 for Patheon Biologics Australia Pty Ltd.?
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